Biosimilars need a shorter road to approval, study argues

Establishing a regulatory approval pathway for new “biosimilar” drugs that’s shorter than the process required for new drugs and biologics could make for significant cost savings for consumers, according to an article published Monday in Health Affairs.

While generics have been on the market as cheaper alternatives to brand-name chemical medicines for decades, biologic alternatives are not identical to their brand-name analogs because they are derived from living organisms.

Until 2010, biosimilars had no pathway for Food and Drug Administration approval. RAND Corp. has estimated the savings that could come from introduction of biosimilars into the drug market at around $44 billion over the next decade.

As federal regulators prepare to decide whether to approve the first biosimilar, experts have expressed concerns over whether current legislation could hamper price competition and undermine the goal of creating a cheaper alternative to biologic medications.

Indeed, study authors contend that barriers still exist for biosimilar producers that could hamper more entering the market and limit competition between such drugs and the biologic medications.

“While many factors will have an effect on the characteristics of the resulting market, the extent of competition and ultimate value delivered to patients will depend on the nature of future FDA rulemaking, as well as the ability of payers and pharmacy benefit managers to adapt to an uncertain and changing landscape,” the article concluded.

A federal advisory panel in January recommended FDA approval of a Novartis cancer drug as a biosimilar alternative to Amgen's Neupogen. Called Zarxio, it is the first such designation approved in the U.S.

Biosimilars have been on the market in Europe since 2006, but have stalled in the U.S. as biologic manufacturers, who have had years of market exclusivity with their medications, have tried to block or delay their introduction into the U.S. as a number of still unanswered questions over such products still linger.

One question is over the issue of interchangeability, or the ability of pharmacists to substitute biosimilar drugs for brand-name medications without fear of any adverse effects.

Insurers and pharmacy benefit managers such as Express Scripts have come out in support of approving biosimilars, estimating the approval of Zarxio could generate as much as $5.7 billion in savings over the next decade. Biosimilar supporters have called for an approval pathway that’s less stringent than that required for new drug applications, and in some ways similar to the process for generic drugs.

The study called for FDA final guidelines that better clarify the evidence and data that will be needed for biosimilars to get approved.

The agency has yet to issue final guidance on the process in which these types of products will be tested for safety and efficacy. Already the FDA has indicated that the standard will be higher than what's in place for generic drugs.

Supporters are concerned that if the process is too similar to that required for a new drug, the result could mean delaying the time and increasing the cost it takes biosimilars to get to the market.

An FDA decision over approval of Zarxio is expected sometime in May, with two biosimilars pending agency approval.